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ADAM & EVE
Model 08859798104917 · SURETEX LIMITED - BRANCH · DI 08859798104917
HIS — Condom · Class II · 21 CFR 884.5300
UDILibrary device dossier · generated 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-05
0
1
2019-11
0
1
2020-05
0
1
2020-10
0
1
2020-11
0
1
2021-08
0
1
2021-12
0
1
2022-01
0
1
2022-03
0
1
2022-05
0
1
2022-10
0
2
2022-12
0
1
2023-07
0
1
2024-12
0
1
2025-07
0
1
2025-08
0
2
2025-11
0
2
This device (reports/month)Average device in HIS (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K941258 — cited as predicate by K163107
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — SURETEX LIMITED - BRANCH